Kornimate/medical-research-clean huggingface dataset:
study evaluation of the efficacy, safety and immunogenicity of adalimumab in comparison with humira®

Conditions: Plaque Psoriasis

Summary: mabps-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of adalimumab (manufactured by mabscale, llc) compared to humira®. the purpose of the study is to demonstrate efficacy, immunogenicity and safety of adalimumab (manufactured by mabscale, llc) to humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.

adalimumab is a recombinant humanized monoclonal antibody currently being developed by mabscale llc, as a proposed biosimilar to humira®, which is approved as treatment in patients with chronic plaque psoriasis. this randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg. 3. established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening. 4. plaque psoriasis of moderate or severe severity of stable course with: * pasi ≥ 12 points; * bsa ≥ 10 %; * spga ≥ 3 points. 5. patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy. exclusion criteria: 1. data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations. 2. a history of severe hypersensitivity reactions of any etiology. 3. other (other than plaque) forms of psoriasis. 4. drug-induced psoriasis. 5. data on the use of the adalimumab or any preparations of monoclonal antibodies inhibiting tnf-α at any time during life. 6. the presence of adalimumab antibodies. 7. extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period. 8. active or latent tuberculosis 9. lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma. 10. any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured. 11. confirmed coronavirus infection caused by covid-19 within 8 weeks prior to the screening period. 12. anamnestic data on the presence of syphilis, viral hepatitis b, viral hepatitis c, hiv. 13. vaccination with live or attenuated vaccines within 8 weeks before the screening period. 14. hepatic and/or renal insufficiency. 15. pregnancy or lactation.
long-term comparative cerebrovascular outcome after transplantation vs standard care in sickle cell anemia

Conditions: Sickle Cell Disease; Cerebral Ischemia; Stenosis

Summary: the purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial doppler-detected cerebral vasculopathy included in the national "sickle cell transplant" protocol and whose 1- and 3-year results were published in jama (journal of the american medical association) in 2019 and in bhj in 2020.

the present observational study has the objective to reevaluate at distance the cohort of 67 children with sickle cell anemia enrolled in the "drepagreffe"trial because of cerebral vasculopathy detected by transcranial doppler. results at 1 and 3 years were reported in jama in 2019 in bhj in 2020. this trial was the first worldwide prospective study comparing transplantation to standard care in sickle cell disease. velocities were highly significantly more reduced with a higher proportion of patients with normalized velocities and better quality of life after transplantation than on standard care. despite a trend to a better ischemic lesions outcome at 3 years, the difference was not significant and cognitive performances were not different between both groups. the biologic study only assessed at enrollment and 1-year showed lower levels of ang-2 and hgf (hepatocyte growth factor) after transplant and a significant and independent association between doppler normalization probability with low ang-2 and bdnf (brain-derived neurotrophic factor) levels.the aim of the present study is to reassess at 9-10 years this cohort with grants allowing to reevaluate cognitive functioning and hypoxia/angiogenic factors not realized in the systematic cohort follow-up

Eligibility criteria:
inclusion criteria: * patient of legal age or minor who participated in the drepagreffe research protocol \[nct 01340404\] between december 2010 and june 2013, * having read and understood the information letter exclusion criteria: * refusal to participate * patient deceased

Keywords: transplantation
pilot study of safety and tolerability of nutrifriend cachexia in nsclc cachexia

Conditions: Cachexia; NSCLC

Summary: sf-c002 is a pilot study in patients with newly diagnosed nsclc suffering from involuntary weight loss. the study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of nutrifriend cachexia.

this study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. the primary objective is to evaluate the safety and tolerability of nutrifriend cachexia in patients with nsclc. the secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and quality of life.

Eligibility criteria:
inclusion criteria: * first-line standard chemotherapy as curative or palliative treatment for nsclc * will start the first cycle of standard chemotherapy * eastern cooperative oncology group (ecog) performance status of ≤2 * involuntary weight loss exclusion criteria: * another invasive malignancy in the last 2 years. * previous relapse of nsclc within 2 years of randomisation * other cachectic disorders such as renal or hepatic disorders
effect of chewing gum on abdominal distension in patients after lumbar spine surgery

Conditions: Lumbar Spondylosis

Summary: according to chewing gum can promote the recovery of gastrointestinal function, it is used as an intervention measure for patients after lumbar surgery to evaluate the effect of chewing gum on improving abdominal distension of patients after lumbar surgery, so as to provide basis for the application and promotion of chewing gum in lumbar postoperative nursing

in this study, the patients after lumbar surgery were given chewing gum after anesthesia. the exhaust time, defecation time and the incidence of abdominal distension of the two groups were compared, and the significance of chewing gum in improving abdominal distension after lumbar surgery was discussed

Eligibility criteria:
inclusion criteria: * the subjects aged 18 years or above were able to chew together; * good at listening, speaking, reading and writing; * lumbar degenerative disease was definitely diagnosed; * general anesthesia was used; * methods: posterior lumbar decompression, bone graft fusion and internal fixation; * no history of gum allergy; exclusion criteria: * none

Keywords: lumbar degenerate diseases postoperative management abdominal distension
association between a mother's exposure to "strep throat" and her baby's developing heart disease

Conditions: Congenital Heart Disease in Pregnancy

Summary: the goal of this study is to find out if there is any association between a mother's exposure to bacteria that normally causes "strep throat" and her baby's developing heart disease/heart defect.

the primary objective of this study is to: 1. measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among hypoplastic left heart syndrome (hlhs) mothers. 2. define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at \<18 weeks gestation and followed to term. 3. measure antibodies that may cross react to select valvular/myocardial antigens in hlhs/congenital heart defect(chd)-other neonates born to mothers in the study 4. determine serum and/or tissue reactivity against antibodies in matched maternal serum. the secondary objectives of this study is to: 1. measure maternal ß-hemolytic streptococcal serology using standard serology testing among hlhs mothers. 2. determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among hlhs mothers. 3. determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at \<18 weeks gestation and followed to term. the overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups a, g and c ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects 4. to determine if co-infections play a role in congenital heart defects

Eligibility criteria:
inclusion criteria: * for fetal pts: * hlhs or variant diagnosis * other congenital heart disease * greater than or = 20wks gestation * for healthy moms: * no diagnosis of congenital heart disease * greater than or = 20wks gestation exclusion criteria: * for fetal pts \& healthy controls: * mom less than 18 years old * twins or multiple gestations * pregnancy affected by 2 or more congenital anomalies( in addition to heart defects) * pregnancy affected by ob complications like pre-eclampsia * known history of chromosomal anomaly or carrier status * pregnancy result of fertility treatment including in vitro fertilization * emotionally distress * mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.

Keywords: strep exposure and heart defects
foot orthoses & hallux limitus in school-age children

Conditions: Hallux Limitus

Summary: the most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.

in the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis. for the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed. if any structure or movement is altered, the axis varies. in the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus. it is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.

Eligibility criteria:
inclusion criteria: * interest in participating and completing the phases of the study and signing of the informed consent by the parents. patients who do not meet any exclusion criteria will be included. exclusion criteria: * the exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.

Keywords: school-age hallux limitus plantar pressures
suhexiang pill for acute ischemic stroke: a registry study

Conditions: Ischemic Stroke

Summary: the primary purpose of this study is to investigate the effectiveness and safety of the suhexiang pill for patients with acute ischemic stroke in real-world settings.

suhexiang pill, a traditional chinese patent medicine, is widely used in china for acute stroke. however, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. this registry study will recruit 1000 patients who receive suhexiang pill treatment after acute ischemic stroke.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke within 7 days of symptom onset. * age ≥ 18 * patient who has received suhexiang pill treatment * patient or legally authorized representative has signed informed consent. exclusion criteria: * be allergic to suhexiang pill * known to be pregnant or breastfeeding. * with conditions that render outcomes or follow-up unlikely to be assessed.

Keywords: acute ischemic stroke traditional chinese medicine registry study
revealing engagement dynamics among semantic dementia patients

Conditions: Semantic Dementia

Summary: the study intends to investigate the personal experiences of semantic dementia patients who take part in a separate clinical study including a specific medication intervention. the major focus will be on closely following individuals' rates of trial completion and withdrawal. the data collected from this study will help improve future outcomes for all semantic dementia as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patients diagnosed with semantic dementia * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * refusal of consent * women of childbearing potential without a negative pregnancy test; or women who are lactating. * any serious and/or unstable pre-existing medical disorders

Keywords: semantic dementia
compative study of pe in thrombosed avf after balloon thrombectomy vs. thromboaspiration.

Conditions: Pulmonary Embolism and Thrombosis

Summary: the goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (pte), assessed through angioct, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (avf). the main questions it aims to answer are: * what is the difference in the incidence of pulmonary thromboembolism (pte) assessed by angioct in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems? * what is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems? * what is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems? * what are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas? participants will be underwent to balloon thrombectomy versus thromboaspiration systems. researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of pe is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.


Eligibility criteria:
inclusion criteria: * patients with acute thrombosis (\< 10 days) of native or prosthetic avf. exclusion criteria: * known pulmonary hypertension. * severe pulmonary disease. * low cardiopulmonary reserve. * recent creation of vascular access. * known right left shunt. * access infection. * allergy to iodinated contrast. * patients under 18 years old.
the health outcomes management and evaluation (home) study

Conditions: Diabetes; Hyperlipidemia; Heart Disease; High Blood Pressure

Summary: there is an urgent need to develop practical, sustainable approaches to improving medical care for persons treated in community mental health settings. this study will test a novel approach for improving mental health consumers based on a partnership model between a community mental health center and a community health center. when this study is completed, it will provide a model for a medical home for persons with severe mental illness that is clinically robust, and organizationally and financially sustainable

findings of excess cardiometabolic morbidity and mortality in persons with severe mental illness (smi) have led to a growing interest by community mental health centers (cmhcs) in improving the medical care of the populations they treat. however, these organizations face a number of financial and organizational barriers to implementing and sustaining such programs. in previous and ongoing work, the study team has documented the promise of team-based models in improving health and health care in this population. this study will test a novel approach for improving mental health consumers based on a partnership model between a cmhc and a community health center (chc). this partnership will capitalize on collocation of services, the primary care expertise of the chc, and favorable reimbursement conditions, to develop a program that is both clinically robust and financially and organizationally sustainable a total of 300 cmhc clients with a severe mental illness and one or more active cardiometabolic problem (diabetes, hypertension, hyperlipidemia) will be randomized to either onsite integrated community care (icc) (n=150) or to a referral to the partner community health center (chc) (n=150) for their medical problems. for those in the icc, the chc will establish a satellite clinic at the cmhc staffed by a physician assistant and care manager. the icc will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities. the study will use standardized, validated instruments to assess the impact of integrated community care on quality and outcomes of cardiometabolic and general medical care. a budget impact analysis will be used to assess the program's financial and organizational sustainability. when this study is completed, it will provide a model for cmhcs to provide a medical home for the populations they serve.

Eligibility criteria:
inclusion criteria: * patient at cobb county csb * one or more of the following conditions: hyperlipidemia, high blood pressure, heart failure, diabetes * able to give consent exclusion criteria: * unable to give consent * does not have a cardiometabolic condition
collaborative organizational approach to selecting and tailoring implementation strategies

Conditions: Psychological Trauma; Mental Health

Summary: the purpose of this study is to partner with the north carolina child treatment program (nc ctp) and the samhsa-funded national child traumatic stress network (nctsn) to develop and pilot the collaborative organizational approach to selecting and tailoring implementation strategies (coast-is). the coast-is intervention will involve coaching organizational leaders and therapists to use intervention mapping to select and tailor strategies. intervention mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. after collaboratively developing coast-is in year 1, the investigators will conduct a randomized pilot trial of the intervention within an nc ctp learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus coast-is condition. participants will include organizational leaders (e.g., ceos/directors, clinical directors, supervisors) and therapists (e.g., licensed clinical social workers, licensed psychologists, licensed professional counselors). the investigators will evaluate coast-is in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of coast-is; 2) to evaluate organizational stakeholders' fidelity to the core elements of intervention mapping; and 3) to demonstrate the feasibility of testing coast-is in a larger effectiveness trial. this work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. ultimately, coast-is may have the potential to improve implementation and sustainment of a wide-range of ebps in mental health and other health sectors.


Eligibility criteria:
* employed at an organization participating in a north carolina child treatment program tf-cbt learning collaborative * working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist * direct involvement in the organization's implementation of tf-cbt

Keywords: implementation science cognitive behavioral therapy children youth
anti ku antibodies and its relationship with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a multi system autoimmune disorder abroad spectrum of clinical presentations. diagnosis of sle depending on systemic lupus international collaborating clinics (slicc) criteria. slicc criteria requires either that a patient satisfy at least 4 of 17 criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with sle in the presence of antinuclear antibodies (ana)or anti_double stranded dna (dsdna) antibodies. anti_ku antibodies included in (ana), reported in many autoimmune disorders like sle,sjogren syndrome, idiopathic lung fibrosis and myositis. so the aim of the work is to determine the relationship between anti_ku antibodies and sle manifestations.


Eligibility criteria:
inclusion criteria: * all patients will fulfill the systemic lupus international clinics(slicc) classification criteria for systemic lupus erythematosus. exclusion criteria: * any patient with any collagen disease other than sle
laparoscopic vs vaginal hysterectomy for benign gynaecological disease

Conditions: Benign Gynecological Disease

Summary: this study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in ain shams university maternity hospital.

the current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in ain shams university maternity hospital, a major tertiary hospital in greater cairo, and one of egypt's leading centers in terms of provision of public medical service. eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: lh or vh.

Eligibility criteria:
inclusion criteria: * women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids). exclusion criteria: women with: * known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses * known neoplasia requiring pelvic lymphadenectomy * pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele * conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (bmi 30 kg/m2 or more) * large uteri interfering with vaginal hysterectomy (size \>16 gestational weeks)